Working at Freudenberg: We will wow your world!

Responsibilities:

• Build and lead internal teams and external vendors, suppliers, and contractors to ensure projects meet scope, schedule, cost, and quality targets while resolving deviations, risks, and resource constraints proactively.

• Serve as primary point of contact for customers, clinicians, and Freudenberg Medical key stakeholders, providing regular updates, managing expectations, product deliverables, and negotiating changes in project scope, budget, or timelines.

• Oversee project budgeting, internal billing, and transfer cost of goods sold (TCOGS) development in collaboration with Finance and Operations, support quote generation and pricing strategy.

• Evaluate new business opportunities, participate in quoting and proposal development, and collaborate with Sales to close deals aligned with strategic goals.

• Allocate appropriate internal resources, monitor utilization, lead “make or buy” decisions, and maintain comprehensive project documentation to ensure compliance and readiness for audits.

• Manage multiple complex or larger-scale projects with strategic impact or high-risk profile to achieve defined scope, schedule, and budget performance goals.

• Knowledge of and managing efforts for compliance using PMBOK principles, in compliance with ISO standards, country-specific (FDA, MDR, Health Canada, PMDA, etc.), GMP regulations, and customer requirements.

• Oversee design history files, device master records, risk analyses, and validation protocols/reports (IQ/OQ/PQ) to ensure designs, processes, equipment, and products meet client, regulatory, and business needs.

• Provide technical and project-management leadership, set priorities, allocate tasks, mentor team members, and foster a culture of efficiency, innovation, and regulatory excellence across the organization.

• Establish, track, and report key performance metrics for development, project progression, and launch; champion continuous improvement through GROWTTH methodologies and Lean/Six Sigma activities to boost quality, delivery, and cost.

• Maintain project documentation in line with internal procedures and notified-body expectations, supporting audits and ensuring robust change-control and traceability. 

• Prepare reports and project summaries to communicate the status of projects on a regular basis.

Qualifications:

• Bachelor's/University degree in Engineering, Chemistry, Biology, or related science/technical field. 

• 5+ years’ experience Medical Device or related industry.

• 4+ years’ experience in Project Management in a manufacturing environment, with advanced experience of leading work within a project plan framework, including managing a schedule, budget, scope, progress, and reporting. 

• Prior experience with silicone material, plastics, and/or extrusions.

• In-depth understanding of engineering and manufacturing processes used in medical device production, such as running equipment, injection molding, extrusion, catheter manufacturing, and assembly, including the materials used. 

• Advanced experience with formal problem-solving methodologies, critical thinking, and deductive skills. 

• Deep understanding of ISO standards, particularly ISO 13485, ISO 14001, ISO 14971.  Knowledge of GMP principles and their application in medical device manufacturing, including country-specific regulatory requirements (i.e., 21 CFR 820 in the United States). 

• Demonstrated experience using Lean/Six Sigma tools as necessary for new and continuous improvement projects. 

• Demonstrated experience providing leadership and managing multiple projects of high complexity. 

• May train new team members and provide input to employee performance evaluations.

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The Freudenberg Group is an equal opportunity employer that is committed to diversity and inclusion. Employment opportunities are available to all applicants and associates without regard to race, color, religion, creed, gender (including pregnancy, childbirth, breastfeeding, or related medical conditions), gender identity or expression, national origin, ancestry, age, mental or physical disability, genetic information, marital status, familial status, sexual orientation, protected military or veteran status, or any other characteristic protected by applicable law.

Freudenberg Medical srl.